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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory To Continuous Ventilator (Respirator)
510(k) Number K052751
Device Name VENTLINK SYSTEM
Applicant
Mediserve Information Systems, Inc.
3225 S. Hardy Dr., Suite 101
Tempe,  AZ  85282
Applicant Contact MARK OFORI-KYEI
Correspondent
Mediserve Information Systems, Inc.
3225 S. Hardy Dr., Suite 101
Tempe,  AZ  85282
Correspondent Contact MARK OFORI-KYEI
Regulation Number868.5895
Classification Product Code
MOD  
Date Received09/30/2005
Decision Date 12/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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